Influence of 100% oxygen inhaled under hyperbaric conditions in patients with symptoms after COVID-19 infection.

Hyperbaric Oxygenation for patients with post-COVID-19 sequelae. Pilot study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001126-21-AT

Enrollment

Registered

2021-04-08

Start date

2021-04-14

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiorgan symptoms after COVID-19 infection (Long COVID)

Interventions

Trade Name: Oxygen Product Name: Sauerstoff medizinisch – Air Liquide Product Code: V03AN01 Pharmaceutical Form: Inhalation vapour INN or Proposed INN: OXYGEN CAS Number: 7782-44-7 Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 18-90 years - Persistent, predominantly pulmonary symptoms with no or little tendency for remission, necessitating in-patient treatment at rehabilitation unit. - No active COVID-19 disease (as documented by three subsequent negative PCR-tests at three days intervals). - Subject willing and able to read, understand and sign an informed consent and to do self-reporting according to questionnaire. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: - Active malignancy - HBO-treatment for any reason prior to study enrolment - Chest pathology incompatible with pressure changes (including untreated pneumothorax, bullous emphysema, moderate to severe asthma) - Ear or sinus pathology incompatible with pressure changes - Pregnancy or lactation - Patients unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the current study is to investigate the feasibility, safety and success of hyperbaric oxygen therapy in patients suffering from multiorgan symptoms after having contracted a COVID-19 infection (i.e. "Long COVID").;Secondary Objective: Not applicable.;Primary end point(s): Feasibility, safety and success of hyperbaric oxygen therapy in Long COVID patients as assessed via: - Chest x-ray - Neurological status - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire - Pulse-oxymetry - Blood pressure - Heart rate - Blood gases - Need for oxygen-supplementation;Timepoint(s) of evaluation of this end point: 1. Before and at the end of treatment: - Chest x-ray - Neurological status - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire 2. Before, after the 1st, after the 6th, and after the last treatment - Pulse Oxymetry 3. Regularly during HBO-treatment - Blood pressure - Heart rate - Blood gases - Need for oxygen-supplementation	—

Measure

Time frame

Main Objective: The aim of the current study is to investigate the feasibility, safety and success of hyperbaric oxygen therapy in patients suffering from multiorgan symptoms after having contracted a COVID-19 infection (i.e. "Long COVID").;Secondary Objective: Not applicable.;Primary end point(s): Feasibility, safety and success of hyperbaric oxygen therapy in Long COVID patients as assessed via: - Chest x-ray - Neurological status - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire - Pulse-oxymetry - Blood pressure - Heart rate - Blood gases - Need for oxygen-supplementation;Timepoint(s) of evaluation of this end point: 1. Before and at the end of treatment: - Chest x-ray - Neurological status - Laboratory parameters (including Trop-T, D-Dimer, WBC, RBC, IL-6, CRP, Ferritin, CoV-19 antibodies) - SF-36 questionnaire 2. Before, after the 1st, after the 6th, and after the last treatment - Pulse Oxymetry 3. Regularly during HBO-treatment - Blood pressure - Heart rate - Blood gases - Need for oxygen-supplementation

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Austria

Contacts

Public ContactClinical Trials Information

Medical University of Graz

freyja.smolle@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026